Rusan Pharma, a global pharma company specialising in addiction treatment and pain management, has reached two significant milestones for its dedicated high-speed transdermal patch and oral film manufacturing facility at the Kandla Special Economic Zone (SEZ)-UNIT-II in Gujarat, India. The facility has recently received Good Manufacturing Practice (GMP) approval from Australia’s Therapeutic Goods Administration (TGA) and a GMP extension from the Brazilian Health Regulatory Agency, ANVISA.
The TGA approval marks an important step in Rusan Pharma’s expansion into the Australian market. After a thorough on-site inspection earlier this year, the GMP certification includes the manufacturing of transdermal patches. These drug delivery systems are designed to address medical needs in pain management and addiction treatment.
Dr Kunal Saxena, Managing Director of Rusan Pharma, stated, “We are delighted that our dedicated transdermal patch and oral film manufacturing facility in Kandla SEZ (Unit II), Gujarat, has received A1 GMP compliance certification from the TGA, Australia. This is the second time the TGA has inspected and approved Rusan’s Kandla Unit-II facility. By achieving this certification, we are well-positioned to introduce our specialized formulations, including Buprenorphine, Nicotine Transdermal Patches, and Buprenorphine+Naloxone Sublingual Films, to the Australian market. This accomplishment reflects our commitment to innovation, quality, and enhancing patient care through advanced pharmaceutical solutions.”
Dr Saxena also noted that the GMP certification not only supports Rusan Pharma’s entry into Australia but also aligns with the company’s goal to enhance its global export capabilities for niche finished formulations.
At the same time, Rusan Pharma has secured an extension of its GMP approval from ANVISA for its transdermal patch facility. This milestone solidifies the company’s position in the growing Brazilian pharmaceutical market. The approval allows Rusan Pharma to expand its product portfolio in Brazil with various products, including Buprenorphine, Donepezil, Loxoprofen, Lidocaine, Diclofenac, Rotigotine, Rivastigmine, and Nicotine patches.
Dr Saxena added, “With the ANVISA GMP approvals of our Active Pharmaceutical Ingredient (API) facility, GCP approval of our CRO – Quantys Clinical Pvt (QCPL) and now the successful extension of the GMP status of the Kandla Unit-II facility for transdermal patches and oral films, Rusan has become a one-stop-solution provider for companies who are looking for in-licensing our niche transdermal patches and oral films for the Brazilian or the LATAM countries. This milestone underscores our ongoing commitment to delivering high-quality healthcare solutions to patients across Brazil.”
These dual achievements in TGA and ANVISA GMP approvals highlight Rusan Pharma’s strategic focus on expanding its global presence while maintaining high standards in regulatory compliance and innovation. As the company continues to strengthen its export capabilities, these certifications reinforce Rusan Pharma’s vision of becoming a trusted global healthcare partner, providing advanced solutions that improve patient outcomes and quality of life.
The post appeared first on .